PMA P910061
- Device
- Sofport® Advanced Optics Posterior Chamber Intraocular Lens (IOL)
- Applicant
- Bausch & Lomb
- PMA number
- P910061
- Supplement
- S027
- Product code
- HQL
- Decision date
- 2022-01-19
- Generic name
- intraocular lens
- Approval order statement
- Updating the raw material specification for one chemical used in the formulation of the polishing slurry for the intraocular lenses.
Current openFDA PMA Record#
- Device
- Sofport® Advanced Optics Posterior Chamber Intraocular Lens (IOL)
- Applicant
- Bausch & Lomb
- PMA number
- P910061
- Supplement
- S027
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2022-01-19
- Decision code
- OK30
- Date received
- 2021-12-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Updating the raw material specification for one chemical used in the formulation of the polishing slurry for the intraocular lenses.